A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)

The registered record

Accession number

NCT06799520

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (industry)

Registered condition naming hair loss

Alopecia Areata (AA)

Also registered on this record

Systemic Lupus Erythematosus (SLE)Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)

Official title

A Phase 1 Open-label Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Subcutaneous VIS171 in Participants With Autoimmune Disease(s)

The first row holds the registered condition that placed this trial on the pipeline; the second holds everything else the sponsor registered on the same record. Both are shown, and shown apart rather than shaded differently, because leaving the second out would make this trial look more like a hair-loss study than its registration says it is — and because a distinction carried only by colour is not a distinction for every reader.

Interventions

• DrugVIS171

Names and types as registered. The sponsors' free-text descriptions of these interventions are not reproduced: they are written by the party with an interest in the result, and reprinting them inside this site's layout would lend them this site's voice.

Design

Study type

interventional

Phase

Phase 1

Allocation

na

Masking

none

Primary purpose

treatment

Enrolment

30 participants (estimated)

Sites

6 locations in Bulgaria, Moldova, Romania, Spain

What it measures

1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) Graded by Severity

   Time frame: From first dose of the study drug up to end of the study (up to Week 45)

Primary outcome measures only, as registered. What a trial chose to measure, and when, is the most informative thing about it that is knowable before it reports — a hair-count endpoint at 24 weeks and a patient-satisfaction endpoint at 12 weeks are not the same study.

Who can take part

Sex

all

Age

18 Years to 75 Years

Healthy volunteers

not accepted

A summary of three registered fields, not the eligibility criteria. The full inclusion and exclusion criteria, the recruiting sites and the study contacts are on the registry record, which is the only place they are maintained. This site has no relationship with this trial and cannot refer anyone to it.

Registered dates

Study start

17 March 2025 (actual)

Primary completion

19 October 2026 (estimated)

Study completion

19 February 2027 (estimated)

First posted

29 January 2025 (actual)

Last update posted

22 July 2026 (actual)

"Estimated" and "actual" are the registry's own labels: an estimated date is a plan, and plans move. A date is printed at the precision it was registered at: this record registers a primary completion to the day, so a day is what is shown. Where a sponsor registers only a month, only a month is shown.

Results

This trial has not reported results. ClinicalTrials.gov holds no results record for it. That is the ordinary state of a trial that is running or about to run, and it means there is nothing here to tell you about whether the intervention works — including nothing negative. If this page implied otherwise it would be wrong.

On this site

Guides covering the condition this trial is registered for. They are about published evidence; this page is about a registration, and the two do not overlap.

Alopecia Areata: Types, Treatment, and OutlookJAK Inhibitors for Alopecia Areata: Baricitinib, Ritlecitinib and Deuruxolitinib, Trial by Trial

Where this came from

Read from the ClinicalTrials.gov API on 6 September 2026 and rebuilt into this page without alteration. ClinicalTrials.gov is a service of the U.S. National Library of Medicine and is the authority on this record; where this page and the registry disagree, the registry is right. This page is not affiliated with or endorsed by NLM or NIH, or with the sponsor of this trial.

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